FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
REMOTE HAND CONTROL TO THE INFLATABLE POSITIONING CUSHION (A.K.A. IMAGEAIR)
K Number: K980235
·
Decision Apr 9, 1998
Classifications
1
FEI Numbers
26
Registration Numbers
26
Same Product Code
175
Applicant Total
3
Review Days
77
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- REMOTE HAND CONTROL TO THE INFLATABLE POSITIONING CUSHION (A.K.A. IMAGEAIR)
- K Number
- K980235
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.1710
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Kci New Technologies, Inc.
- Date Received
- January 22, 1998
- Decision Date
- April 9, 1998
- Product Code
- IZH
- Advisory Committee
- Radiology
- Review Advisory Committee
- RA
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| IZH | System, X-Ray, Mammographic | FDA class 2 | Radiology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (IZH), ordered by most recent decision date.
SMART FINDER
FDA 510(k)
FDA Class 2
·Radiology
Affirm Contrast Biopsy
FDA 510(k)
FDA Class 2
·Radiology
Biopsy Positioner
FDA 510(k)
FDA Class 2
·Radiology
Affirm Lateral Arm Upright Biopsy Accessory
FDA 510(k)
FDA Class 2
·Radiology
Comfort Cover
FDA 510(k)
FDA Class 2
·Radiology
Affirm Prone Biopsy System
FDA 510(k)
FDA Class 2
·Radiology